Multiple MyelomaPhase 2NCT00427765
Busulfan Plus Melphalan Conditioning Regimen for Lymphoid Malignancies or Multiple Myeloma
A Phase 2 study testing Busulfan and Melphalan in people with Multiple Myeloma and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 mMol-min for 4 days, followed by… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma, Lymphoma
- What is being tested?
- Busulfan and Melphalan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Nov 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lymphoid malignancies, including Hodgkin's and non-Hodgkin's lymphoma (primary refractory or recurrent), or multiple myeloma (beyond first complete remission or unresponsive to therapy. Complete remission for multiple myeloma defined by absence of detectable paraprotein in serum and/or urine by immunoelectrophoresis or immunofixation, and < 5% plasma cells in the bone marrow), not qualifying for treatment protocols of higher priority.
- Age 18 to 65 years of age.
- Adequate renal function as defined by estimated serum creatinine clearance > 50 ml/min and serum creatinine < 1.8 mg/dL.
- Adequate hepatic function, as defined by serum glutamic pyruvic transaminase (SGPT) < 3 * upper limit of normal; serum bilirubin and alkaline phosphatase < 2 * upper limit of normal, or considered not clinically significant.
- Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and Capacity of the Lung for Carbon Monoxide (DLCO)> 50%. Exceptions may be allowed for patients with pulmonary involvement after discussing with principal investigator (PI).
- Adequate cardiac function with left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
Show all 10Show fewer
- Zubrod performance score < 2.
- Patients receiving an allogeneic transplant must have an HLA matched, or one A, B, or DR mismatched related donor. Unrelated donor must be matched at A, B, and DR (defined as A, B serologic matched and DRB1 molecular matched). Donor must be willing to donate peripheral blood or bone marrow progenitor cells.
- Patient and donor should be willing to participate in the study by providing written consent.
- Female patient must not be pregnant and have negative pregnancy.
Who cannot join
- Patients with unresolved grade >/= 3 non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the PI.
- Patients with active Central Nervous System (CNS) disease.
- Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.
- Uncontrolled infection, including Human immunodeficiency virus (HIV) or Human T-lymphotropic virus Type I (HTLV-1) infection.
- Patients who have had a previous autologous or allogeneic stem cell transplant during the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of High-Dose Intravenous Busulfan Plus Melphalan With Allogeneic or Autologous Marrow or Peripheral Blood Progenitor Cell Transplantation for Lymphoid Malignancies or Multiple Myeloma
Primary Objectives:
- To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in adult patients receiving autologous or allogeneic transplantation for lymphoid malignancies or myeloma.
- To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this regimen.
- To determine the disease-free and overall survival of patients receiving this preparative regimen.
- To determine the treatment-related morbidity and mortality of this combination of drugs.
Read the detailed description
Busulfan and melphalan are both traditional alkylating agents that are designed to interfere with the production of cancer cells at the DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) level.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete physical exam, including routine blood (2-3 teaspoons) and urine tests. Patients will have a chest x-ray, heart scan, lung function test, and a bone marrow biopsy. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will be able to start receiving chemotherapy treatment with busulfan and melphalan. Participants who agree to the optional blood draws described above will at first receive a therapeutic "trial dose" of busulfan by vein to test the blood levels over time. This therapeutic trial dose of busulfan is about 25% (1 fourth) of the full therapeutic dose of the drug. This information will be used to decide what the future high-dose busulfan treatments you receive will be. If you do not agree to the optional blood draw, you will receive a fixed amount of high-dose busulfan from the start.
On the 1st day of hospitalization, you will receive fluids by vein through a central venous catheter. If you choose the optional busulfan dose for pharmacokinetic-based busulfan dosing, you will receive the optional busulfan dose 9 days before stem cell infusion (Day 1), followed by a rest day on Day 2. If you choose to receive a fixed dose of busulfan, busulfan will be injected through a central venous catheter over 3 hours, once a day, for the next 4 days (Days 3-6, ending 3 days before the stem cell infusion day).
Patients receiving pharmacokinetic-based dosing of busulfan will also continue to receive busulfan on Days 3-6. This will be followed by melphalan for all patients, given through your central venous catheter over 30 minutes, once a day, for 2 days, on days 8 and 9. Your stem cell infusion day will be on Day 10 of treatment.
Patients receiving 5 out of 6 antigen matched-related allogeneic stem cell transplants or unrelated allogeneic stem cell transplants will also receive antithymocyte globulin (ATG), by vein, on Days 7-9, up to one day before the stem cell infusion. This is given to decrease the risk of GVHD and graft rejection in mismatched transplants.
On Day 10, healthy blood stem cells or bone marrow from the donor will be given through the central catheter. This is your transplant date. You will also receive several other medications to help the treatment work and to help prevent infections while your immune system is weak. Tacrolimus and methotrexate will be given to decrease the risk of graft-versus-host-disease (GVHD). GVHD occurs when the donor's immune cells fight the patient's body. The tacrolimus will be started on the day before the transplant and will continue for up to six months. Tacrolimus is given by vein at first and then by mouth when you are able to eat. Methotrexate is given by vein on Days 11, 13, 16, and possibly on Day 21, up to 11 days after the transplant.
Please note that the treatment dates listed above were used to help explain your general treatment plan. By standard medical convention, the day of stem cell infusion is always listed as day zero. Therefore, the days listed above are different from the treatment plan described in the protocol and abstract.
Sulfamethoxazole (Bactrim) or pentamidine will be given to fight bacteria. Bactrim is given by mouth when the counts are good. Pentamidine is given by vein when the counts are low. Acyclovir will be given at first by vein and then Valtrex (valacyclovir) will be given by pill to decrease the risk of viral infections. Granulocyte colony-stimulating factor (G-CSF) will be given to help the new bone marrow grow. It is given as an injection under the skin after the transplant. It will continue until the white blood cells reach an acceptable level. Overall, some of these drugs will be given for as long as 6 months or possibly longer. Other medications may be necessary. If you are allergic to some of these drugs, changes will be made.
You will be in the hospital for about 3-4 weeks. You will have checkups every day until discharged from the hospital. You will then be seen in the outpatient clinic at least 3 times a week until your blood counts improve. You will be seen by your doctor at least every week until 100 days after the bone marrow transplant. You must stay in Houston during this time. After 100 days, you will return to the clinic according to your individual physician's recommendations.
Some patients may need to receive spinal taps with instillation of chemotherapy several times over the year after transplantation. This is only for patients with a previous clinical history of leukemic involvement of the brain or high risk of developing leukemia relapse in the brain. The spinal tap is performed in the clinic. You are given local anesthetic at the lower back site, a small needle is inserted in the space between 2 spinal bones, a small amount of fluid that bathes the brain (cerebrospinal fluid) is removed for testing, and a small amount of chemotherapy is given.
Bone marrow samples will be taken at about 1 month and 3 months after the transplant. You will also have a lung function test at 3 months after the transplant.
This is an investigational study. The FDA has approved all of the drugs used in this study for use in stem cell transplantation. Up to 168 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Multiple Myeloma, Lymphoma
- Keywords
- Multiple Myeloma, Hodgkin's Disease, Non-Hodgkin's Lymphoma, Leukemia, Lymphoma, Busulfan, Melphalan, Autologous bone marrow, BMT, Peripheral blood stem cell transplant, PBSCT
- Medical subject headings
- Multiple Myeloma, Lymphoma, Hodgkin Disease, Lymphoma, Non-Hodgkin, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BusulfanDrug
Also called Busulfex
Test Dose = 32 mg/m^2 IV for 1 Day; 130 mg/m^2 IV for 4 Days
MelphalanDrug
70 mg/m^2 IV for 2 Days
| Study group | Role | What they receive |
|---|---|---|
| Busulfan + Melphalan | Experimental | Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days Receives: Drug: Busulfan; Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Overall Survival Time
Average number of years for survival post transplant where overall survival time is measured from date of transplant to disease progression or death for any reason.
Measured: Baseline(transplantation) to disease progression or death for any reason, up to 6 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startDec 2004
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Partow Kebriaei, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427765
- Sponsor's protocol ID
- 2004-0190
- Status last verified
- Dec 2011
- First submitted
- 25 Jan 2007
- Last updated
- 19 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nieto Y, Gruschkus S, Valdez BC, Jones RB, Anderlini P, Hosing C, Popat U, Qazilbash M, Kebriaei P, Alousi A, Saini N, Srour S, Rezvani K, Ramdial J, Barnett M, Gulbis A, Shigle TL, Ahmed S, Iyer S, Lee H, Nair R, Parmar S, Steiner R, Dabaja B, Pinnix C, Gunther J, Cuglievan B, Mahadeo K, Khazal S, Chuang H, Champlin R, Shpall EJ, Andersson BS. Improved outcomes of high-risk relapsed Hodgkin lymphoma patients after high-dose chemotherapy: a 15-year analysis. Haematologica. 2022 Apr 1;107(4):899-908. doi: 10.3324/haematol.2021.278311.
PubMed 33951890
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of High-Dose Intravenous Busulfan Plus Melphalan With Allogeneic or Autologous Marrow or Peripheral Blood Progenitor Cell Transplantation for Lymphoid Malignancies or Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00427765
- Acronym / sponsor ID
- 2004-0190
- Conditions
- Multiple Myeloma, Lymphoma
- Keywords
- Multiple Myeloma, Hodgkin's Disease, Non-Hodgkin's Lymphoma, Leukemia, Lymphoma, Busulfan, Melphalan, Autologous bone marrow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Posted 19 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in adult patients receiving autologous or allogeneic transplantation for lymphoid malignancies or myeloma.
- To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this regimen.
- To determine the disease-free and overall survival of patients receiving this preparative regimen.
- To determine the treatment-related morbidity and mortality of this combination of drugs.
Detailed description
Busulfan and melphalan are both traditional alkylating agents that are designed to interfere with the production of cancer cells at the DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) level.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete physical exam, including routine blood (2-3 teaspoons) and urine tests. Patients will have a chest x-ray, heart scan, lung function test, and a bone marrow biopsy. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will be able to start receiving chemotherapy treatment with busulfan and melphalan. Participants who agree to the optional blood draws described above will at first receive a therapeutic "trial dose" of busulfan by vein to test the blood levels over time. This therapeutic trial dose of busulfan is about 25% (1 fourth) of the full therapeutic dose of the drug. This information will be used to decide what the future high-dose busulfan treatments you receive will be. If you do not agree to the optional blood draw, you will receive a fixed amount of high-dose busulfan from the start.
On the 1st day of hospitalization, you will receive fluids by vein through a central venous catheter. If you choose the optional busulfan dose for pharmacokinetic-based busulfan dosing, you will receive the optional busulfan dose 9 days before stem cell infusion (Day 1), followed by a rest day on Day 2. If you choose to receive a fixed dose of busulfan, busulfan will be injected through a central venous catheter over 3 hours, once a day, for the next 4 days (Days 3-6, ending 3 days before the stem cell infusion day).
Patients receiving pharmacokinetic-based dosing of busulfan will also continue to receive busulfan on Days 3-6. This will be followed by melphalan for all patients, given through your central venous catheter over 30 minutes, once a day, for 2 days, on days 8 and 9. Your stem cell infusion day will be on Day 10 of treatment.
Patients receiving 5 out of 6 antigen matched-related allogeneic stem cell transplants or unrelated allogeneic stem cell transplants will also receive antithymocyte globulin (ATG), by vein, on Days 7-9, up to one day before the stem cell infusion. This is given to decrease the risk of GVHD and graft rejection in mismatched transplants.
On Day 10, healthy blood stem cells or bone marrow from the donor will be given through the central catheter. This is your transplant date. You will also receive several other medications to help the treatment work and to help prevent infections while your immune system is weak. Tacrolimus and methotrexate will be given to decrease the risk of graft-versus-host-disease (GVHD). GVHD occurs when the donor's immune cells fight the patient's body. The tacrolimus will be started on the day before the transplant and will continue for up to six months. Tacrolimus is given by vein at first and then by mouth when you are able to eat. Methotrexate is given by vein on Days 11, 13, 16, and possibly on Day 21, up to 11 days after the transplant.
Please note that the treatment dates listed above were used to help explain your general treatment plan. By standard medical convention, the day of stem cell infusion is always listed as day zero. Therefore, the days listed above are different from the treatment plan described in the protocol and abstract.
Sulfamethoxazole (Bactrim) or pentamidine will be given to fight bacteria. Bactrim is given by mouth when the counts are good. Pentamidine is given by vein when the counts are low. Acyclovir will be given at first by vein and then Valtrex (valacyclovir) will be given by pill to decrease the risk of viral infections. Granulocyte colony-stimulating factor (G-CSF) will be given to help the new bone marrow grow. It is given as an injection under the skin after the transplant. It will continue until the white blood cells reach an acceptable level. Overall, some of these drugs will be given for as long as 6 months or possibly longer. Other medications may be necessary. If you are allergic to some of these drugs, changes will be made.
You will be in the hospital for about 3-4 weeks. You will have checkups every day until discharged from the hospital. You will then be seen in the outpatient clinic at least 3 times a week until your blood counts improve. You will be seen by your doctor at least every week until 100 days after the bone marrow transplant. You must stay in Houston during this time. After 100 days, you will return to the clinic according to your individual physician's recommendations.
Some patients may need to receive spinal taps with instillation of chemotherapy several times over the year after transplantation. This is only for patients with a previous clinical history of leukemic involvement of the brain or high risk of developing leukemia relapse in the brain. The spinal tap is performed in the clinic. You are given local anesthetic at the lower back site, a small needle is inserted in the space between 2 spinal bones, a small amount of fluid that bathes the brain (cerebrospinal fluid) is removed for testing, and a small amount of chemotherapy is given.
Bone marrow samples will be taken at about 1 month and 3 months after the transplant. You will also have a lung function test at 3 months after the transplant.
This is an investigational study. The FDA has approved all of the drugs used in this study for use in stem cell transplantation. Up to 168 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Busulfan + Melphalan | Experimental | Drug: Busulfan, Drug: MelphalanBusulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with lymphoid malignancies, including Hodgkin's and non-Hodgkin's lymphoma (primary refractory or recurrent), or multiple myeloma (beyond first complete remission or unresponsive to therapy. Complete remission for multiple myeloma defined by absence of detectable paraprotein in serum and/or urine by immunoelectrophoresis or immunofixation, and < 5% plasma cells in the bone marrow), not qualifying for treatment protocols of higher priority.
- Age 18 to 65 years of age.
- Adequate renal function as defined by estimated serum creatinine clearance > 50 ml/min and serum creatinine < 1.8 mg/dL.
- Adequate hepatic function, as defined by serum glutamic pyruvic transaminase (SGPT) < 3 * upper limit of normal; serum bilirubin and alkaline phosphatase < 2 * upper limit of normal, or considered not clinically significant.
- Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and Capacity of the Lung for Carbon Monoxide (DLCO)> 50%. Exceptions may be allowed for patients with pulmonary involvement after discussing with principal investigator (PI).
Key exclusion criteria (5 listed)
- Patients with unresolved grade >/= 3 non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the PI.
- Patients with active Central Nervous System (CNS) disease.
- Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.
- Uncontrolled infection, including Human immunodeficiency virus (HIV) or Human T-lymphotropic virus Type I (HTLV-1) infection.
- Patients who have had a previous autologous or allogeneic stem cell transplant during the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BusulfanAlso: BusulfexTest Dose = 32 mg/m^2 IV for 1 Day; 130 mg/m^2 IV for 4 Days | Drug | Busulfan + Melphalan |
| Melphalan70 mg/m^2 IV for 2 Days | Drug | Busulfan + Melphalan |
Primary outcome
Average Overall Survival Time
Time frame: Baseline(transplantation) to disease progression or death for any reason, up to 6 years.
Average number of years for survival post transplant where overall survival time is measured from date of transplant to disease progression or death for any reason.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33951890Nieto Y, Gruschkus S, Valdez BC, Jones RB, Anderlini P, Hosing C, Popat U, Qazilbash M, Kebriaei P, Alousi A, Saini N, Srour S, Rezvani K, Ramdial J, Barnett M, Gulbis A, Shigle TL, Ahmed S, Iyer S, Lee H, Nair R, Parmar S, Steiner R, Dabaja B, Pinnix C, Gunther J, Cuglievan B, Mahadeo K, Khazal S, Chuang H, Champlin R, Shpall EJ, Andersson BS. Improved outcomes of high-risk relapsed Hodgkin lymphoma patients after high-dose chemotherapy: a 15-year analysis. Haematologica. 2022 Apr 1;107(4):899-908. doi: 10.3324/haematol.2021.278311.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Multiple Myeloma
RecruitingPhase 1/2
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
RecruitingObservational study
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Smoldering Multiple Myeloma
RecruitingPhase 1/2
Study of Carfilzomib, Lenalidomide, Dexamethasone and Belantamab Mafodotin in Multiple Myeloma
Multiple Myeloma
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Partow Kebriaei, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Busulfan and Melphalan in people with Multiple Myeloma and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Overall Survival Time (time frame: Baseline(transplantation) to disease progression or death for any reason, up to 6 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00427765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.